The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol

BMC Musculoskeletal Disorders

Søren Overgaard¹  Anders Holsgaard-Larsen¹  Carsten Jensen¹  Leif Broeng²  Signe Rosenlund² 

[1]Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark

[2]Department of Orthopedic Surgery and Traumatology, Køge Hospital, Køge, Denmark

关键词: Surgical approach;    Hip replacement;    Osteoarthritis;   

Others  :  1118637
DOI  :  10.1186/1471-2474-15-354

 received in 2013-08-12, accepted in 2014-10-09,  发布年份 2014

【 摘 要 】

Background

Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes, including physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year.

Methods/Design

The trial is a prospective, double blinded, parallel-group controlled trial with balanced randomisation [1: 1]. Patients with hip osteoarthritis scheduled for hip replacement surgery, aged 45–70 years, will be consecutively recruited and randomised into two groups. Group A will receive hip replacement using the posterior approach, and Group B will receive hip replacement using the lateral approach. The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery. Follow-up will also be performed after three and six months. The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.

Discussion

To our knowledge, this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up.

Trial registration

Clinicaltrial.gov:NCT01616667.

【 授权许可】

   
2014 Rosenlund et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY: Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am 2004, 86-A:963-974.
• [2]Nilsdotter AK, Petersson IF, Roos EM, Lohmander LS: Predictors of patient relevant outcome after total hip replacement for osteoarthritis: a prospective study. Ann Rheum Dis 2003, 62:923-930.
• [3]Steiner C, Andrews R, Barrett M, Weiss A: HCUP Projections Report # 2012-03. In HCUP Projections: Mobility/Orthopedic Procedures 2011 to 2012. U.S. Agency for Healthcare Research and Quality; 2012. ONLINE September 20, 2012. [ http://www.hcup-us.ahrq.gov/reports/projections/2012-03.pdf webcite]
• [4]Annual Report 2009, Danish Hip Arthroplasty Registry. March 2010 2009. [ http://www.dhr.dk/Ny%20mappe/rapporter/DHR%20Aarsrapport_2009%20t_web.pdf webcite]
• [5]Havelin LI, Fenstad AM, Salomonsson R, Mehnert F, Furnes O, Overgaard S, Pedersen AB, Herberts P, Karrholm J, Garellick G: The Nordic Arthroplasty Register Association: a unique collaboration between 3 national hip arthroplasty registries with 280,201 THRs. Acta Orthop 2009, 80:393-401.
• [6]Palan J, Beard DJ, Murray DW, Andrew JG, Nolan J: Which approach for total hip arthroplasty: anterolateral or posterior? Clin Orthop Relat Res 2009, 467:473-477.
• [7]Jolles BM, Bogoch ER: Posterior versus lateral surgical approach for total hip arthroplasty in adults with osteoarthritis. Cochrane Database Syst Rev 2004. Issue 3. Art. No.: CD003828
• [8]Arthursson AJ, Furnes O, Espehaug B, Havelin LI, Soreide JA: Prosthesis survival after total hip arthroplasty–does surgical approach matter? Analysis of 19,304 Charnley and 6,002 Exeter primary total hip arthroplasties reported to the Norwegian Arthroplasty Register. Acta Orthop 2007, 78:719-729.
• [9]Hailer NP, Weiss RJ, Stark A, Karrholm J: The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. Acta Orthop 2012, 83:442-448.
• [10]Pellicci PM, Bostrom M, Poss R: Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res 1998, 355:224-228.
• [11]Smith AJ, Wylde V, Berstock JR, Maclean AD, Blom AW: Surgical approach and patient-reported outcomes after total hip replacement. Hip Int 2012, 22(4):355-361.
• [12]Edmunds CT, Boscainos PJ: Effect of surgical approach for total hip replacement on hip function using Harris Hip scores and Trendelenburg’s test. A retrospective analysis. Surgeon 2011, 9:124-129.
• [13]Masonis JL, Bourne RB: Surgical approach, abductor function, and total hip arthroplasty dislocation. Clin Orthop Relat Res 2002, 405:46-53.
• [14]Mulliken BD, Rorabeck CH, Bourne RB, Nayak N: A modified direct lateral approach in total hip arthroplasty: a comprehensive review. J Arthroplasty 1998, 13:737-747.
• [15]Gore DR, Murray MP, Sepic SB, Gardner GM: Anterolateral compared to posterior approach in total hip arthroplasty: differences in component positioning, hip strength, and hip motion. Clin Orthop Relat Res 1982, 165:180-187.
• [16]Baker AS, Bitounis VC: Abductor function after total hip replacement. An electromyographic and clinical review. J Bone Joint Surg Br 1989, 71:47-50.
• [17]Madsen MS, Ritter MA, Morris HH, Meding JB, Berend ME, Faris PM, Vardaxis VG: The effect of total hip arthroplasty surgical approach on gait. J Orthop Res 2004, 22:44-50.
• [18]Witzleb WC, Stephan L, Krummenauer F, Neuke A, Gunther KP: Short-term outcome after posterior versus lateral surgical approach for total hip arthroplasty - A randomized clinical trial. Eur J Med Res 2009, 14:256-263. BioMed Central Full Text
• [19]Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869.
• [20]Hoppenfeld S, de Boer P, Buckley R: The Hip. In Surgical Exposures in Orthopaedics the Anatomic Approach. 4th edition. Philadelphia: Lippincott Williams & Wilkins; 2009:403-462.
• [21]Davis AM, Perruccio AV, Canizares M, Tennant A, Hawker GA, Conaghan PG, Roos EM, Jordan JM, Maillefert JF, Dougados M, Lohmander LS: The development of a short measure of physical function for hip OA HOOS-Physical Function Shortform (HOOS-PS): an OARSI/OMERACT initiative. Osteoarthritis Cartilage 2008, 16:551-559.
• [22]Thorborg K, Roos EM, Bartels EM, Petersen J, Holmich P: Validity, reliability and responsiveness of patient-reported outcome questionnaires when assessing hip and groin disability: a systematic review. Br J Sports Med 2010, 44:1186-1196.
• [23]Nilsdotter AK, Lohmander LS, Klassbo M, Roos EM: Hip disability and osteoarthritis outcome score (HOOS)–validity and responsiveness in total hip replacement. BMC Musculoskelet Disord 2003, 4:10. BioMed Central Full Text
• [24]Davis AM, Perruccio AV, Canizares M, Hawker GA, Roos EM, Maillefert JF, Lohmander LS: Comparative, validity and responsiveness of the HOOS-PS and KOOS-PS to the WOMAC physical function subscale in total joint replacement for osteoarthritis. Osteoarthritis Cartilage 2009, 17:843-847.
• [25]de Groot IB, Reijman M, Terwee CB, Bierma-Zeinstra SM, Favejee M, Roos EM, Verhaar JA: Validation of the Dutch version of the Hip disability and Osteoarthritis Outcome Score. Osteoarthritis Cartilage 2007, 15:104-109.
• [26]Beyer N, Thorborg K, Vinther A: Translation and Cross-Cultural Adaptation of the Danish Version of the Hip Dysfunction and Osteoarthritis Outcome Score 2.0 (HOOS 2.0). 2008. [ http://koos.nu/index.html webcite]
• [27]Brooks R: EuroQol: the current state of play. Health Policy 1996, 37:53-72.
• [28]Fransen M, Edmonds J: Reliability and validity of the EuroQol in patients with osteoarthritis of the knee. Rheumatology (Oxford) 1999, 38:807-813.
• [29]Ashby E, Grocott MP, Haddad FS: Outcome measures for orthopaedic interventions on the hip. J Bone Joint Surg Br 2008, 90:545-549.
• [30]van Agt HM, Essink-Bot ML, Krabbe PF, Bonsel GJ: Test-retest reliability of health state valuations collected with the EuroQol questionnaire. Soc Sci Med 1994, 39:1537-1544.
• [31]Harrison MJ, Davies LM, Bansback NJ, Ingram M, Anis AH, Symmons DP: The validity and responsiveness of generic utility measures in rheumatoid arthritis: a review. J Rheumatol 2008, 35:592-602.
• [32]Tidermark J, Bergstrom G, Svensson O, Tornkvist H, Ponzer S: Responsiveness of the EuroQol (EQ 5-D) and the SF-36 in elderly patients with displaced femoral neck fractures. Qual Life Res 2003, 12:1069-1079.
• [33]Paulsen A, Pedersen AB, Overgaard S, Roos EM: Feasibility of 4 patient-reported outcome measures in a registry setting. Acta Orthop 2012, 83:321-327.
• [34]Translation Process- EuroQol. [ http://www.euroqol.org/eq-5d-products/translation-process.html webcite]
• [35]Terwee CB, Bouwmeester W, van Elsland SL, de Vet HC, Dekker J: Instruments to assess physical activity in patients with osteoarthritis of the hip or knee: a systematic review of measurement properties. Osteoarthritis Cartilage 2011, 19:620-633.
• [36]Naal FD, Impellizzeri FM, Leunig M: Which is the best activity rating scale for patients undergoing total joint arthroplasty? Clin Orthop Relat Res 2009, 467:958-965.
• [37]Beaule PE, Dorey FJ, Hoke R, Le DM, Amstutz HC: The value of patient activity level in the outcome of total hip arthroplasty. J Arthroplasty 2006, 21:547-552.
• [38]Soderman P, Malchau H: Is the Harris hip score system useful to study the outcome of total hip replacement? Clin Orthop Relat Res 2001, 384:189-197.
• [39]Villadsen A, Roos EM, Overgaard S, Holsgaard-Larsen A: Agreement and reliability of functional performance and muscle power in patients with advanced osteoarthritis of the hip or knee. Am J Phys Med Rehabil 2012, 91:401-410.
• [40]Podsiadlo D, Richardson S: The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991, 39:142-148.
• [41]Yeung TS, Wessel J, Stratford PW, MacDermid JC: The timed up and go test for use on an inpatient orthopaedic rehabilitation ward. J Orthop Sports Phys Ther 2008, 38:410-417.
• [42]Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L: Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty 2011, 26:728-737.
• [43]Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D: Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord 2005, 6:3. BioMed Central Full Text
• [44]Wright AA, Cook CE, Baxter GD, Dockerty JD, Abbott JH: A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. J Orthop Sports Phys Ther 2011, 41:319-327.
• [45]Dobson F, Hinman RS, Hall M, Terwee CB, Roos EM, Bennell KL: Measurement properties of performance-based measures to assess physical function in hip and knee osteoarthritis: a systematic review. Osteoarthritis Cartilage 2012, 20:1548-1562.
• [46]Jones CJ, Rikli RE, Beam WC: A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport 1999, 70:113-119.
• [47]Gill S, McBurney H: Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int 2008, 13:141-152.
• [48]Bremander AB, Dahl LL, Roos EM: Validity and reliability of functional performance tests in meniscectomized patients with or without knee osteoarthritis. Scand J Med Sci Sports 2007, 17:120-127.
• [49]Hardcastle P, Nade S: The significance of the Trendelenburg test. J Bone Joint Surg Br 1985, 67:741-746.
• [50]Kendall KD, Patel C, Wiley JP, Pohl MB, Emery CA, Ferber R: Steps towards the validation of the Trendelenburg test: the effect of experimentally reduced hip abductor muscle function on frontal plane mechanics. Clin J Sport Med 2012.
• [51]Kendall KD, Schmidt C, Ferber R: The relationship between hip-abductor strength and the magnitude of pelvic drop in patients with low back pain. J Sport Rehabil 2010, 19:422-435.
• [52]Bergmann TF, Peterson DH, Lawrence DJ: Extraspinal Techniques. In Chiropractic Techniques. New York: Churchill Livingstone Inc; 1993.
• [53]Poulsen E, Christensen HW, Penny JO, Overgaard S, Vach W, Hartvigsen J: Reproducibility of range of motion and muscle strength measurements in patients with hip osteoarthritis - an inter-rater study. BMC Musculoskelet Disord 2012, 13:242. BioMed Central Full Text
• [54]Schwartz MH, Rozumalski A: The Gait Deviation Index: a new comprehensive index of gait pathology. Gait Posture 2008, 28:351-357.
• [55]Pospischill M, Kranzl A, Attwenger B, Knahr K: Minimally invasive compared with traditional transgluteal approach for total hip arthroplasty: a comparative gait analysis. J Bone Joint Surg Am 2010, 92:328-337.
• [56]Foucher KC, Hurwitz DE, Wimmer MA: Preoperative gait adaptations persist one year after surgery in clinically well-functioning total hip replacement patients. J Biomech 2007, 40:3432-3437.
• [57]Molloy M, McDowell BC, Kerr C, Cosgrove AP: Further evidence of validity of the Gait Deviation Index. Gait Posture 2010, 31:479-482.
• [58]Jensen C, Aagaard P, Overgaard S: Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial. Osteoarthritis Cartilage 2011, 19:1108-1116.
• [59]SENIAM EMG Guidelines. [ http://www.seniam.org webcite]
• [60]Perron M, Malouin F, Moffet H, McFadyen BJ: Three-dimensional gait analysis in women with a total hip arthroplasty. Clin Biomech (Bristol, Avon) 2000, 15:504-515.
• [61]Burden AM, Trew M, Baltzopoulos V: Normalisation of gait EMGs: a re-examination. J Electromyogr Kinesiol 2003, 13:519-532.
• [62]Burden A: How should we normalize electromyograms obtained from healthy participants? What we have learned from over 25 years of research. J Electromyogr Kinesiol 2010, 20:1023-1035.
• [63]Bergh I, Sjostrom B, Oden A, Steen B: An application of pain rating scales in geriatric patients. Aging (Milano) 2000, 12:380-387.
• [64]Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P: OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008, 16:137-162.
• [65]Paulsen A, Overgaard S, Lauritsen JM: Quality of data entry using single entry, double entry and automated forms processing-an example based on a study of patient-reported outcomes. PLoS One 2012, 7:e35087.
• [66]Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N: Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol 2000, 27:2635-2641.
• [67]Roos EM, Lohmander LS: The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 2003, 1:64. BioMed Central Full Text
• [68]Terwee CB, Roorda LD, Knol DL, De Boer MR, De Vet HC: Linking measurement error to minimal important change of patient-reported outcomes. J Clin Epidemiol 2009, 62:1062-1067.
• [69]KOOS FAQs [ http://koos.nu/index.html webcite]
• [70]Frison L, Pocock SJ: Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med 1992, 11:1685-1704.
• [71]Cimolin V, Galli M, Vimercati SL, Albertini G: Use of the Gait Deviation Index for the assessment of gastrocnemius fascia lengthening in children with Cerebral Palsy. Res Dev Disabil 2011, 32:377-381.
• [72]Rosenlund S, Nielsen DB, Overgaard S, Jensen C, Holsgaard-Larsen A: Is gait velocity and gait quality associated with hip muscle strength in hip osteoarthritis patients scheduled for total hip arthroplasty? Osteoarthritis Cartilage 2014, 22:S116-S117.
• [73]Rabe-Hesketh S, Skrondal A: Multilevel and Longitudinal Modeling using Stata. 2nd edition. Edited by Newton HJ. Texas: Stata Press; 2008.
• [74]Cohen J: A power primer. Psychol Bull 1992, 112:155-159.
• [75]Sainani KL: Making sense of intention-to-treat. PMR 2010, 2:209-213.
• [76]Rantanen T, Avlund K, Suominen H, Schroll M, Frandin K, Pertti E: Muscle strength as a predictor of onset of ADL dependence in people aged 75 years. Aging Clin Exp Res 2002, 14:10-15.
• [77]Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, Altman R, Brandt K, Dougados M, Lequesne M: Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 1997, 24:799-802.
• [78]Kiyama T, Naito M, Shinoda T, Maeyama A: Hip abductor strengths after total hip arthroplasty via the lateral and posterolateral approaches. J Arthroplasty 2010, 25:76-80.
• [79]Klausmeier V, Lugade V, Jewett BA, Collis DK, Chou LS: Is there faster recovery with an anterior or anterolateral THA? A pilot study. Clin Orthop Relat Res 2010, 468:533-541.
• [80]Rasch A, Dalen N, Berg HE: Muscle strength, gait, and balance in 20 patients with hip osteoarthritis followed for 2 years after THA. Acta Orthop 2010, 81:183-188.
• [81]Downing ND, Clark DI, Hutchinson JW, Colclough K, Howard PW: Hip abductor strength following total hip arthroplasty: a prospective comparison of the posterior and lateral approach in 100 patients. Acta Orthop Scand 2001, 72:215-220.
• [82]Beaulieu ML, Lamontagne M, Beaule PE: Lower limb biomechanics during gait do not return to normal following total hip arthroplasty. Gait Posture 2010, 32:269-273.
• [83]Ewen AM, Stewart S, St Clair GA, Kashyap SN, Caplan N: Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture 2012, 36:1-6.
• [84]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309.